# K960385: Sterile Kirschner Wires and Steinmann Pins

- Pathway: 510(k) (Traditional)
- Applicant: Depuy, Inc.
- Decided: Mar 27, 1996 after 61 days
- Product code: HTY (Pin, Fixation, Smooth)
- Device class: 2
- Regulation: 21 CFR 888.3040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
146 later devices descend from it; 17 cite it directly.
0 of 147 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) DePuy Non-sterile Kirschner Wires and Steinmann Pins: named in the summary without a submission number

## Most influential descendants
- K022599: Newdeal K Wire (2002), 118 descendants of its own
- K101165: Pro-Toe VO Hammertow Implant System (2010), 80 descendants of its own
- K070598: Memometal Intra-Medullary Bone Fastener, Models Smart Toe / X-Fuse (2007), 72 descendants of its own
- K120645: Pro-Toe (TM) VO Hamertoe Implant System-Line Sddition (2012), 61 descendants of its own
- K070555: Orthopro Steinman Pins and Kirschner Wires (2007), 37 descendants of its own

## Indications for use
The Sterile Kirschner Wires and Steinmann Pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Source page: https://510kreport.com/device/K960385
Methodology: https://510kreport.com/methodology